Kornimate/medical-research-clean huggingface dataset:
adherence to treatment with tecfidera™ in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the investigators are measuring the adherence rates of an oral ms drug that is to be administered twice-daily. the investigators would like to observe any patterns that might indicate factors that greatly affect adherence.


Eligibility criteria:
inclusion criteria: * must give written informed consent and any authorizations required by local law (e.g., protected health information \[phi\]). * aged 18 at the time of informed consent. * must have a relapsing form of ms. * male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. exclusion criteria: * progressive form of ms * history of severe allergic or anaphylactic reactions or known drug hypersensitivity. * female subjects considering becoming pregnant while in the study. * female subjects who are currently pregnant or breast-feeding. * unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol. * any other reason that, in opinion of the investigator and/or the sponsor, the subject is determined to be unsuitable for enrollment in this study.

Keywords: multiple sclerosis tecfidera(r) oral medication adherence
lifestyle behavior influences among african american patients with stage 0-iii prostate cancer survivors and their partners

Conditions: Cancer Survivor; Partner; Spouse; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8

Summary: this trial studies the day-to-day stress, social support, and health lifestyle behaviors (such as physical activity and nutrition) in african american patients with stage 0-iii prostate cancer survivors and their partners. how patients cope with stress may affect their lifestyle behaviors. this study may help understand not only survivors' behaviors but also partners' behaviors and how they interact.

primary objectives: i. examine temporal associations between dyadic coping and health behaviors such as physical activity and diet. ii. identify social and physical contexts in which health behaviors occur/co-occur among survivors and their partners. exploratory objective: i. investigate potential moderators for the associations between stress and dyadic coping. outline: patients and partners complete questionnaires over 60 minutes about demographic information, stress, coping, and lifestyle behaviors at baseline and end of study. patients and partners also receive an accelerometer and complete ecological momentary assessment (ema) questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes four time daily (qid; 7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone application (app) for 14 days. patients and partners also complete a survey on nutrition twice weekly (biw) for a total of 4 surveys.

Eligibility criteria:
inclusion criteria: * survivors are eligible if they self-identify as african american adults * had stage 0-iii prostate cancer (no restriction on time elapsed since diagnosis) * completed adjuvant therapy (i.e., chemo and/or radiation therapy) * live together with a current partner/spouse who is eligible for the study * do not need physical assistance (e.g., wheelchair, cane) * have a smartphone * can read and speak english * currently are not participating in a health behavior or weight management program * men on active surveillance will be included * partners are eligible if they are adults * partners are eligible if they do not have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia) * partners are eligible if they have a smartphone * partners are eligible if they can read and speak english * partners are eligible if they currently are not participating in a health behavior or weight management program * the dyad can be either married or unmarried and same-sex or heterosexual exclusion criteria: * survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
systematic analysis of a standardized questionnaire to detect possible bleeding disorders and its impact on perioperative hemostasis management

Conditions: Perioperative Hemorrhage; Hemostasis

Summary: with the help of a standardized questionnaire, an increased risk of bleeding due to pre-existing hemostasis disorders in the site-specific patient population will be detected and the corresponding enhanced diagnostic measures will be initiated. the planned prospective observational study should i.) systematically investigate the results of this procedure and ii.) allow a comparison with a retrospective perioperative cohort that was cared for at the benjamin franklin campus before the introduction of the questionnaire. due to the campus structure with a large vascular surgery center as well as a large urological, general and trauma surgery department, a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is to be expected. in the following, the feasibility of the required measures in clinical routine (measured by the frequency of actual changes or modifications of the initially planned perioperative procedure, the adequate implementation of indicated diagnostic measures, etc.) will be examined.

the aim of the study is the systematic scientific evaluation of a standardized questionnaire for bleeding history already used in clinical routine during the preoperative anesthesiological visit and its impact on perioperative coagulation management. the routine use of a standardized questionnaire to assess bleeding risk is based on a study on the preoperative identification of patients with (primary) hemostasis disorders from 2007: in a patient collective of 5649 patients from different disciplines at the charité - universitätsmedizin berlin, a positive predictive value of 99% for the presence of a hemostasis disorder could be established if at least four questions of a standardized bleeding history questionnaire were answered positively. this is not possible in the same way with the plasmatic coagulation-global tests established in clinical routine. the standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy. however, a systematic scientific evaluation of this questionnaire with regard to the conditions at the benjamin franklin campus with a large vascular surgery center as well as a large urological, general and trauma surgery department and a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is still pending.

Eligibility criteria:
inclusion criteria: all adult (age ≥ 18 years) patients of both genders undergoing elective surgery at the benjamin franklin campus in the 12-month period exclusion criteria: * pregnancy, lactation * patients not capable of giving consent * already diagnosed hemostasis disorder * patients under (plasmatic) anticoagulation
study of therapeutic exercise in acute respiratory failure to improve neuromuscular disability trial

Conditions: Critical Illness; Acute Respiratory Failure

Summary: this is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for icu patients with acute respiratory failure within 12 medical and surgical icus across 4 hospitals in the university of pennsylvania health system. the investigators will conduct a 54-week trial to measure the effect of the intervention on multiple patient-centered outcomes of patient physical function and cognition, in addition to icu and hospital length of stay and duration of mechanical ventilation compared to usual care.

the stand trial aims to measure the effect of an early goal-directed mobilization algorithm versus usual care for icu patients with acute respiratory failure in the medical and surgical icus across university of pennsylvania health system (uphs) with respect to patient-centered outcomes of patient physical function and cognition as well as multiple secondary clinical outcomes. to achieve this goal, the investigators will conduct a 54-week stepped-wedge, cluster randomized, trial to test the intervention during the course of providing usual care among a large and diverse population of patients admitted to 12 icus across 4 hospitals within uphs. the intervention is an early mobilization protocol implemented during a patient's stay in the icu. it involves three steps: 1) the clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door; 2) a facilitator will be established in the icu to communicate mobility goals and activities across clinical personnel shifts; 3) patient mobility scores will be displayed to clinical and administrative staff in the icu via the icu board. approximately 1,500 adult patients with continuous mechanical ventilation for ≥48 hours (without interruption) and baseline independent ambulatory status will be enrolled. participating icus will be randomized into 6 clusters of 2 icus each. each icu contributes a minimum of 12 weeks of data under the usual care control condition prior to implementing the early mobilization intervention. then, using the stepped-wedge design, all icus will implement the intervention in 6-week intervals with the order and timing of implementation determined by random assignment. by the end of the trial, all icus will have utilized the intervention for at least 12 weeks. the primary outcome is peak patient activity level as measure by the icu mobility score (ims) at icu discharge. secondary outcomes include an array of clinical outcomes.

Eligibility criteria:
inclusion criteria: * age ≥18 years old; and * admission to 1 of 12 participating icus; and * continuous mechanical ventilation for ≥ 48 hours (without interruption); and * baseline independent ambulatory status exclusion criteria: * admitting diagnosis of any of the following conditions: * cardiopulmonary arrest * raised intracranial pressure * acute neurological admission diagnosis * subarachnoid hemorrhage * ischemic stroke

Keywords: early icu mobility
evaluation of the h-coil transcranial magnetic stimulation(tms) device- augmentation for drug resistant depression

Conditions: Major Depression

Summary: there is a general consensus of efficacy of tms in treatment of major depression,yet results are not satisfying.a new coil ("h"-coil, recently invented in weizmann institute of science, neurobiology department, rehovot, israel) is supposed to be capable of stimulating deeper brain structures than conventional coils.tms using this coil was named by its developers as "deep tms" and will hence be refered to by this name. so far, deep tms have studied in israel with promising sucssess in patients with major depression (an on-going study).a safety study with good results have been recently published.the aim of this study is to reinforce initial results in major depression using deep tms.

a group of 40 patients with major depression will be randomly assigned to deep tms with h-1 coil in frequency of 20 hz or h-2 coil in frequency of 0.1 hz with 120% of motor threshold to the prefrontal cortex . no change in anti-depressant medication one month prior to study is a prerequisite.deep tms will be administered for 4 weeks.during tms exposure subjects will be exposed to a conversation in which they talk about their depression and their ruminations.patients will be evaluated using hamilton depression rating scale (ham-d24),hamilton anxiety rating scale (ham-a),clinical global impression - improvement(cgi-i) ,beck depression inventory (bdi),visual analog scale (vas).

Eligibility criteria:
inclusion criteria: * right handed ,18-65 year old male or female subjects * diagnosed according to dsm-v-tr as suffering from major depression using scid interview * score of 22 or more in the hamilton depression rating scale (ham-d24) * the present depressive episode have been treated with at least 2 different anti-depressive drugs at peak doses for at least 6 weeks with not more than a partial response.augmentation strategies may be included. exclusion criteria: cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort: * history of current hypertension * history of seizure or heat convulsion * history of epilepsy or seizure in first degree relatives * history of head injury * history of any metal in the head (outside the mouth) * known history of any metallic particles in the eye * implanted cardiac pacemaker or any intra-cardiac lines * implanted neuro-stimulators * surgical clips or any medical pumps * history of frequent or severe headaches * history of migraine * history of hearing loss * known history of cochlear implants * history of drug abuse or alcoholism * pregnancy or not using a reliable method of birth control (non-pregnancy will be proved by beta-hcg test) * systemic and metabolic disorders * inadequate communication skills or under custodial care.
distributed registry

Conditions: Peripheral Arterial Disease; Intermittent Claudication; Arteriosclerosis; Atherosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Patient Compliance

Summary: the purpose of this study is to test if a patient can be directly connected to a quality assurance (qa) database, traditionally known as a registry. patient-reported outcomes (pro) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. the investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.


Eligibility criteria:
inclusion criteria: 1. patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure. 2. patients with smartphones (ios or android) with unlimited data plans. 3. patients who agree to remote surveillance exclusion criteria: 1. patients unwilling to download a research study app. 2. data plans which are not unlimited.
frequency of metabolic dysfunction associated fatty liver disease in patients with acute coronary syndromes

Conditions: Fatty Liver

Summary: aim of the research is to assess frequency of mafld among patients with acute coronary syndromes (acs).

hepatic manifestation of metabolic syndrome (ms) is known as metabolic dysfunction associated fatty liver disease (mafld). mafld could be complicated by serious events as steatohepatitis, cirrhosis and malignant liver. the characteristics histological findings in those patients are macrovesicular steatosis. the prevalence of mafld has doubled over the last 20 years. globally, based on many reported studies, it's well-known that in 25-28% of deaths in patients with metabolic dysfunction associated fatty liver disease (mafld) , coronary artery disease (cad) is accused to be the leading cause. patients with mafld are known to have more complex coronary artery disease in angiography. but the effect on clinical outcome and mortality is not known. furthermore, the impact of mafld on acute coronary syndrome (acs) is not clear. moreover, in patients with metabolic syndrome the presence of mafld would be associated with severe form of cad as noticed by angiography where there was increased in number of affected vessels and multivariate regression analysis found that mafld as the only independent factor affecting coronary score. the syntax score was prospectively developed for the syntax trial to grade the anatomical complexity of coronary lesions in patients with lt main coronary arterty (lm) or three-vessel disease . it was found to be an independent predictor of long-term major adverse cardiac and cerebrovascular events (macce) and of death. while the available data clearly support a role of mafld in initiating and progression of cad in non-diabetic patients is still to be searched. mafld might play a part in the pathogenesis of cad through the overexpression and systemic release of several inﬂammatory, hemostatic and oxidative-stress mediators or via contributing to whole-body insulin resistance and atherogenic dyslipidemia. based on the lack of studies that discussed the effect of mafld on patients with acs ,we designed this study trying to asses the effect of mafld on the severity of acs.

Eligibility criteria:
inclusion criteria: any patient above the age of 18 years old presented with acute coronary syndromes {myocardial infarction (mi), non-st elevation myocardial infarction (nstemi), unstable angina} underwent coronary angiography within admission. exclusion criteria: 1. patients refused to participate. 2. patients with history of alcohol or drug abuse. 3. patients have hepatitis c or hepatitis b infection. 4. patients have primary or secondary hepatic malignancies 5. pregnant women.
the effect of obstructive sleep apnea operations on the swallowing function

Conditions: Dysphagia; Sleep Apnea, Obstructive

Summary: the investigators hypothesize that partial robotic tongue base resection surgery and / or soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.in order to characterize the dysphagia the investigators will locate participants undergoing this surgery more than six months ago.the investigators will test their swallowing by fiberoptic endoscopic evaluation of swallowing (fees) and let participants fill out a questionnaire regarding swallowing disorders swallowing dysfunction questionnaire (sdq). also the investigators will use data collected from participants who have undergone this surgery and already had these tests due to swallowing complaints.

first step: the investigators will review the operating room reports, identify participants who underwent trans-oral robotic surgery for base of tongue and/ or soft palate surgery more than six months ago. second step: 1. the investigators will locate and conclude data of participants who already underwent assessment of postoperative swallowing function (fees test and sdq).the investigators will review the summary of their meeting. 2. the investigators will call participants who have not yet done swallowing assessment and invite them to a clinic appointment. third step- participants come to the clinic. receive an explanation, sign a consent form. then the participants fulfill the sdq questionnaire (patient self- filling questionnaire) in which the participants assess the quality swallowing. then the investigators will conduct the swallowing test - fees test. during this test fiber optic fiber is inserted through the participants nose for the purpose of observing the pharyngeal and laryngeal areas.the participants eat and drink food and with different textures while looking for their swallowing mechanism via the optical fiber in order to identify swallowing problems. forth step- two laryngologists and a speech therapists will go over the recorded swallowing tests, filling out the two questionnaires:swallowing performance status scale (spss) and penetration- aspiration scale (pas). with these scales every participant receives a score that reflects the quality of swallowing. a higher score indicates a more severe swallowing disorder.

Eligibility criteria:
inclusion criteria: * participants above 18 years who had robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea. exclusion criteria: * participants who previously underwent surgery or treatments known to be hazardous for swallowing. * participants suffering from a neurological problem that affects the quality of swallowing. * tracheostomized participants.

Keywords: sleep apnea robotic surgery for base of tongue soft palate surgery post operative swallowing evaluation dysphagia
rituximab combining bortezomib versus rituximab in management of itp

Conditions: Immune Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic

Summary: the project was undertaking by qilu hospital of shandong university and other 2 well-known hospitals in china. in order to report the efficacy and safety of rituximab combining with bortezomib for the treatment of adults with immune thrombocytopenia (itp), compared to rituximab alone .

the investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 100 itp adult patients from 3 medical centers in china. one part of the participants are randomly selected to receive rituximab (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally) combining with bortezomib (given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally), the others are selected to receive rituximab alone (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally). platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to rituximab alone therapy for the treatment of adults with itp.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. not previously used rituximab and bortezomid,untreated patients, may be male or female, between the ages of 18 \~ 80 years. 3. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 4. eastern cooperative oncology group（ecog）performance status ≤ 2. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. current hiv infection or hepatitis b virus or hepatitis c virus infections. 3. severe medical condition (lung, hepatic or renal disorder) other than itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 4. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 5. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 6. patients who are deemed unsuitable for the study by the investigator

Keywords: immune thrombocytopenia thrombocytopenia